Optimizing safety reporting for in-trial patient interviews

Patient interviews provide rich insight into participant experience of new treatments, but they also raise questions about how best to handle safety reporting.

In drug development, risk assessment and risk management are key—especially when it comes to spotting and understanding adverse events (AEs). So how can we adapt industry norms for pharmacovigilance reporting in clinical trials to ensure patient safety and compliance during in-trial interviews?  

CLINIGMA^© interviewers—trained anthropologists and social scientists—are skilled at conducting in-trial interviews. They know how to listen and draw out meaningful patient narratives. But because they aren’t medical professionals, they can’t assess causality, expectedness, relatedness, or the seriousness of an AE. That responsibility lies with the sponsor and investigator. As a precaution, any event mentioned in a patient interview that could be a potential (serious) adverse event (P(S)AE) needs to be flagged.

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Reporting All P(S)AEs

One approach is to report all P(S)AEs after the interview, leaving the clinical site to review and act as per the trial protocol. This method helps ensure no AE is missed and reduces the chance of audit citations for failing to report AEs or suspected unexpected serious adverse reactions (SUSARs). However, this approach comes at a cost—reporting every mention, regardless of relevance, can overwhelm regulatory agencies and sponsors with redundant or duplicate data, creating confusion and potentially masking important safety signals.

This challenge isn’t new. Excessive and duplicate reporting should be minimized. Before 2010, the Food and Drug Administration (FDA) found that sponsors frequently reported serious adverse experiences with little evidence of causality, failing to meet the "associated with the use of the drug" requirement for Investigational New Drug (IND) safety reports. Attempting to review these reports is taxing and difficult to resource across institutions. The Agency for Healthcare Research and Quality (AHRQ) recommended developing systems that capture appropriate events while avoiding duplicate reporting. Duplicate reporting creates confusion in data accuracy and can affect safety signal detection. While reporting all P(S)AEs heard during in-trial interviews may seem like the best option, it poses risks that we feel outweigh the benefits. Too much information can actually get in the way of spotting real safety issues.

Using a Screening Question

That’s why we now favor using a screening question in in-trial interviews. Interviewers simply ask participants whether the event has already been reported to the study team. If yes, the interview continues. If no—or if the patient is unsure—the interviewer can revisit the topic at the end of the interview to gather details for proper reporting. This approach keeps the interview flowing so the patient interview stays focused on its core purpose.

There are several advantages to this method, since it:

-       Actively involves patients

-       Reduces the burden on clinical sites

-       Avoids muddying data with second-hand or repeated reports

-       Reduces the incidence of poor recall, since these interviews often happen long after the event occurred.

Compared to spontaneous reporting, this strategy is more targeted and reliable.

Yes, there’s a risk—patients might mistakenly think an event was already reported—but that can be addressed by cross-checking transcripts with the site’s records. When thoughtfully integrated, in-trial interviews become an even more powerful tool—not just for collecting insights, but for strengthening trial safety overall.

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In the end, both approaches aim to protect trial integrity—but using a screening question in in-trial interviews offers a smarter, more streamlined way to ensure quality AE reporting. It lightens the load for staff, includes participants more meaningfully, and keeps the focus on what matters most: safe, compliant, and effective clinical trials.

Choosing the right safety reporting approach ensures compliance, protects participants, and strengthens data integrity across clinical trials.

CLINIGMA^® provides expert solutions in capturing patient feedback in clinical trials in accordance with regulatory requirements. With the largest global network of researchers on the market, we are able to interview patients worldwide, which enables us to accommodate the needs of global pharmaceutical companies.

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References

Food and Drug Administration. (n.d.). Guidance for industry: Premarketing risk assessment (pp. 4–5). U.S. Department of Health and Human Services. https://www.fda.gov/media/71650/download

Food and Drug Administration. (n.d.). Inspectional observation data sets: FY2023 – Drugs. Retrieved November 15, 2024, from https://www.fda.gov/media/174101/download?attachment

Food and Drug Administration. (n.d.). Guidance for industry and investigators: Safety reporting requirements for INDs and BA/BE studies. https://www.fda.gov/files/drugs/published/Safety-Reporting-Requirements-for-INDs-%28Investigational-New-Drug-Applications%29-and-BA-BE-%28Bioavailability-Bioequivalence%29-Studies.pdf

Gliklich, R. E., Leavy, M. B., & Dreyer, N. A. (Eds.). (2020). Registries for evaluating patient outcomes: A user’s guide(4th ed.). Agency for Healthcare Research and Quality. https://www.ncbi.nlm.nih.gov/books/NBK562575/

U.S. Government Publishing Office. (n.d.). Investigational new drug application: Safety reporting requirements (21 CFR §312.32). https://www.ecfr.gov/current/title-21/chapter-I/subchapter-D/part-312/subpart-B/section-312.32

U.S. Government Publishing Office. (n.d.). Transfer of obligations to a contract research organization (21 CFR §312.52). https://www.ecfr.gov/current/title-21/chapter-I/subchapter-D/part-312/subpart-D/section-312.52